Catalog Number

-

Brand Name

CVS Health

Version/Model Number

8000-10737

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

NBW

Product Code Name

System, Test, Blood Glucose, Over The Counter

Public Device Record Key

8bfea952-318e-45de-992d-ef56fd593a52

Public Version Date

July 15, 2019

Public Version Number

1

DI Record Publish Date

July 07, 2019

Package DI Number

10050428618070

Quantity per Package

24

Contains DI Package

00050428618073

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Shipper